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IRADIMED CORPORATION

Matched from indexed company URL: IRADIMED CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30050535603005053560IRADIMED CORPORATION1N2026-01-0112705 Ingenuity Dr Orlando FL US 32826

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
646951745852919K242752MRidium 3870 MRI Infusion Pump System (3870)FRN2025-05-28
646951158556387K1829003880 MRI Patient Monitoring SystemMWI2018-12-14
646951353614523K1809033880 MRI Patient Monitoring SystemMWI2019-03-29
646951787579430K1722003880 MRI Patient Monitoring SystemMWI2017-10-25
646951354845815K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemFRN2016-12-15
646951198321321K090087MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEMFRN2009-04-07
646951004670417K050301MRIDIUM 3850 MRI PUMP SYSTEMFRN2005-03-24
646951509919044
646951858190088

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRN42025-05-28
MWI32019-03-29

PMN#

GUDID#

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